Lung CancerPhase 1/2NCT02638090
Pembro and Vorinostat for Patients With Stage IV Non-small Cell Lung Cancer (NSCLC)
A Phase 1/2 study testing Vorinostat and Pembrolizumab in people with Lung Cancer and Non-small Cell Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The main purpose of this study is to see whether the combination of two drugs called pembrolizumab and vorinostat can help people with advanced lung cancer. Researchers also want to find out if the combination of pembrolizumab and vorinostat is safe and tolerable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-small Cell Lung Cancer
- What is being tested?
- Vorinostat and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2016to Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent/assent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Have archival tissue where available. Those participants enrolled on the phase 1 escalation trial where archival tissue is not available will undergo a fresh biopsy where clinically feasible after discussion with the sponsor.
- In addition, participants enrolled on the phase 1 dose escalation, phase 1 expansion or Phase II trial must be willing and able to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion.
- Randomized Phase II: Tumor proportional score of PD-L1 ≥1%.
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- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Demonstrate adequate organ function.
- Have a histologic or cytologic diagnosis of Stage IV non-small cell lung cancer (NSCLC).
- Phase I/IB (Pre-treated): Have progression from at least one prior line of therapy. Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate regimen of therapy. Participants who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible for these arms. Participants with recurrent disease ≥ 6 months after completing a platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a systemic regimen given to treat the recurrence, must have received another treatment in the first-line metastatic setting.
- Randomized Phase II: Be treatment naïve in the stage IV setting, with the exception of participants whose tumors harbor an activation mutation (including but not limited to EGFR, ALK, ROS1) and were previously treated with targeted therapy. Participants who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease < 6 months of completing therapy are ineligible for this arm. Subjects with recurrent disease ≥ 6 months after completing a platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a systemic regimen given to treat the recurrence, are eligible for this arm.
- Females of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication.
- Males should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Who cannot join
- Is currently participating in and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses ≥ 10 mg prednisone or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if >= 10 mg/day prednisone equivalents. A brief course (≤28 days) of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
- Has a known history of tuberculosis (TB) Disease (Mycobacterium tuberculosis).
- Hypersensitivity to pembrolizumab, vorinostat or any of its excipients.
- Participants enrolled on the phase II randomized trial, who have had prior treatment with a PD1 or PDL1 inhibitor, anti-CTLA 4 antibody or any other antibody or drug that specifically targets immune checkpoint pathway (i.e. not "immune therapy naïve"). -Note: For those enrolled in the phase I dose escalation, prior use of a PD1 or PDL1, anti-CTLA4 antibody or any other antibody or drug that specifically targets immune checkpoint pathway is allowed. For those enrolled in the phase IB, prior use of a PD1 or PDL1, anti-CTLA4 antibody or any other antibody or drug that specifically targets immune checkpoint pathway is required. For all participants in all phases, prior use of a vaccine for treatment of cancer is allowed.
- Participants enrolled in the phase Ib expansion who have never previously been treated with a PD1 or PDL1 inhibitor, anti-CTLA 4 antibody or any other antibody or drug that specifically targets immune checkpoint pathway in the past (i.e. not "pre-treated").
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- Participants who have received thoracic radiation >30Gy within 6 months of the first dose of pembrolizumab.
- Patients taking any HDACi other than vorinostat.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has had prior chemotherapy with 3 weeks, or targeted small molecule therapy or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Patients with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: Patients with any grade alopecia are an exception to this criterion and may qualify for the study.
- If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Previously treated brain metastases may be an exception if stable and specific other criteria are met.
- Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
- Has an active infection requiring systemic therapy.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
- Has a history of, or any evidence of active non-infectious pneumonitis that required or requires steroids.
- Has evidence of interstitial lung disease
- Has a history of symptomatic (NYHA class II-IV) heart failure
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase I/II Study of Pembrolizumab and Vorinostat in Patients With Immune Therapy Naïve and Immune Therapy Pretreated Stage IV NSCLC
The main purpose of this study is to see whether the combination of two drugs called pembrolizumab and vorinostat can help people with advanced lung cancer. Researchers also want to find out if the combination of pembrolizumab and vorinostat is safe and tolerable. This study will compare the effects of the combination of two drugs called pembrolizumab and vorinostat with the effects of pembrolizumab alone. The U.S. Food and Drug Administration (FDA) has approved pembrolizumab for use to treat a deadly skin cancer called melanoma and lung cancer and vorinostat to treat some forms of blood and lymph node cancers.
Read the detailed description
A Phase I/Randomized Phase II clinical trial of pembrolizumab and vorinostat in Eastern Cooperative Oncology Group (ECOG) 0-1 patients with immune therapy naïve and immune therapy pretreated locally advanced or metastatic NSCLC who have progressed through one prior line of therapy.
The begins with a phase I dose escalation utilizing the modified continuous reassessment method (O'Quigley, Pepe, \& Fisher, 1990). This would be followed by a phase I expansion at the maximum tolerated dose (MTD) in 18 NSCLC patients who have been previously treated with anti-PD-1 or anti-PD-L1 therapy. In parallel, a separate phase II arm will randomize 70 patients to a pembrolizumab alone group and a pembrolizumab plus vorinostat group.
- Conditions
- Lung Cancer, Non-small Cell Lung Cancer
- Being tested
- Vorinostat, Pembrolizumab
- Keywords
- advanced lung cancer, immune therapy naive, immune therapy pre-treated, NSCLC, Stage IV lung cancer, pembrolizumab, vorinostat, immunogenicity
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VorinostatDrug
Also called Zolinza
Administered per treatment arm guidelines.
PembrolizumabDrug
Also called KEYTRUDA
Administered per treatment arm guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Phase I Dose Escalation | Experimental | Level 1: Vorinostat 200mg by mouth (PO) Daily; Pembrolizumab 200 mg intravenously (IV) every (Q) 3 weeks.
Level 2: Vorinostat 400 mg PO Daily; Pembrolizumab 200 mg IV Q3 weeks Receives: Drug: Vorinostat; Drug: Pembrolizumab |
| Phase Ib Expansion | Experimental | Pembrolizumab plus Vorinostat.
Level 1: Maximum Tolerated Dose (MTD) Receives: Drug: Vorinostat; Drug: Pembrolizumab |
| Arm A: Pembrolizumab | Active comparator | Pembrolizumab treatment only.
Level 1: Pembrolizumab 200 mg Q3 wks Receives: Drug: Pembrolizumab |
| Arm B: Pembrolizumab plus Vorinostat | Active comparator | Pembrolizumab plus Vorinostat treatment.
Level 1: MTD Receives: Drug: Vorinostat; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Maximum Tolerated Dose (MTD)
The maximum tolerated dose (MTD) corresponding to a risk of dose limiting toxicity (DLT) occurring in 30% of patients. DLTs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03). A DLT will be defined as any Grade 3 or higher toxicity that occurs during the DLT evaluation period. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded from this definition.
Measured: Up to 12 months
Secondary outcomes (1)
Phase II: Progression Free Survival (PFS) Per Treatment Arm
PFS will be measured from the start of treatment with pembrolizumab and vorinostat until the documentation of disease progression or death due to any cause, whichever occurs first. Progression: One or more of the following must occur: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study start22 Mar 2016
- Primary completion21 Jan 2024
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Jhanelle Gray, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638090
- Sponsor's protocol ID
- MCC-18494
- Status last verified
- Sep 2026
- First submitted
- 18 Dec 2015
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Pembrolizumab and Vorinostat in Patients With Immune Therapy Naïve and Immune Therapy Pretreated Stage IV NSCLC
- ClinicalTrials.gov ID
- NCT02638090
- Acronym / sponsor ID
- MCC-18494
- Conditions
- Lung Cancer, Non-small Cell Lung Cancer
- Keywords
- advanced lung cancer, immune therapy naive, immune therapy pre-treated, NSCLC, Stage IV lung cancer, pembrolizumab, vorinostat, immunogenicity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 22 Mar 2016 (actual)
- Primary completion
- 21 Jan 2024 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Posted 4 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to see whether the combination of two drugs called pembrolizumab and vorinostat can help people with advanced lung cancer. Researchers also want to find out if the combination of pembrolizumab and vorinostat is safe and tolerable. This study will compare the effects of the combination of two drugs called pembrolizumab and vorinostat with the effects of pembrolizumab alone. The U.S. Food and Drug Administration (FDA) has approved pembrolizumab for use to treat a deadly skin cancer called melanoma and lung cancer and vorinostat to treat some forms of blood and lymph node cancers.
Detailed description
A Phase I/Randomized Phase II clinical trial of pembrolizumab and vorinostat in Eastern Cooperative Oncology Group (ECOG) 0-1 patients with immune therapy naïve and immune therapy pretreated locally advanced or metastatic NSCLC who have progressed through one prior line of therapy.
The begins with a phase I dose escalation utilizing the modified continuous reassessment method (O'Quigley, Pepe, \& Fisher, 1990). This would be followed by a phase I expansion at the maximum tolerated dose (MTD) in 18 NSCLC patients who have been previously treated with anti-PD-1 or anti-PD-L1 therapy. In parallel, a separate phase II arm will randomize 70 patients to a pembrolizumab alone group and a pembrolizumab plus vorinostat group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase I Dose Escalation | Experimental | Drug: Vorinostat, Drug: PembrolizumabLevel 1: Vorinostat 200mg by mouth (PO) Daily; Pembrolizumab 200 mg intravenously (IV) every (Q) 3 weeks. Level 2: Vorinostat 400 mg PO Daily; Pembrolizumab 200 mg IV Q3 weeks |
| Phase Ib Expansion | Experimental | Drug: Vorinostat, Drug: PembrolizumabPembrolizumab plus Vorinostat. Level 1: Maximum Tolerated Dose (MTD) |
| Arm A: Pembrolizumab | Active comparator | Drug: PembrolizumabPembrolizumab treatment only. Level 1: Pembrolizumab 200 mg Q3 wks |
| Arm B: Pembrolizumab plus Vorinostat | Active comparator | Drug: Vorinostat, Drug: PembrolizumabPembrolizumab plus Vorinostat treatment. Level 1: MTD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Willing and able to provide written informed consent/assent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Have archival tissue where available. Those participants enrolled on the phase 1 escalation trial where archival tissue is not available will undergo a fresh biopsy where clinically feasible after discussion with the sponsor.
- In addition, participants enrolled on the phase 1 dose escalation, phase 1 expansion or Phase II trial must be willing and able to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion.
Key exclusion criteria (22 listed)
- Is currently participating in and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses ≥ 10 mg prednisone or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if >= 10 mg/day prednisone equivalents. A brief course (≤28 days) of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
- Has a known history of tuberculosis (TB) Disease (Mycobacterium tuberculosis).
- Hypersensitivity to pembrolizumab, vorinostat or any of its excipients.
- Participants enrolled on the phase II randomized trial, who have had prior treatment with a PD1 or PDL1 inhibitor, anti-CTLA 4 antibody or any other antibody or drug that specifically targets immune checkpoint pathway (i.e. not "immune therapy naïve"). -Note: For those enrolled in the phase I dose escalation, prior use of a PD1 or PDL1, anti-CTLA4 antibody or any other antibody or drug that specifically targets immune checkpoint pathway is allowed. For those enrolled in the phase IB, prior use of a PD1 or PDL1, anti-CTLA4 antibody or any other antibody or drug that specifically targets immune checkpoint pathway is required. For all participants in all phases, prior use of a vaccine for treatment of cancer is allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VorinostatAlso: ZolinzaAdministered per treatment arm guidelines. | Drug | Arm B: Pembrolizumab plus Vorinostat, Phase I Dose Escalation, Phase Ib Expansion |
| PembrolizumabAlso: KEYTRUDAAdministered per treatment arm guidelines. | Drug | Arm A: Pembrolizumab, Arm B: Pembrolizumab plus Vorinostat, Phase I Dose Escalation, Phase Ib Expansion |
Primary outcome
Phase I: Maximum Tolerated Dose (MTD)
Time frame: Up to 12 months
The maximum tolerated dose (MTD) corresponding to a risk of dose limiting toxicity (DLT) occurring in 30% of patients. DLTs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03). A DLT will be defined as any Grade 3 or higher toxicity that occurs during the DLT evaluation period. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded from this definition.
1 secondary outcome
Phase II: Progression Free Survival (PFS) Per Treatment Arm
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jhanelle Gray, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vorinostat and Pembrolizumab in people with Lung Cancer and Non-small Cell Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Maximum Tolerated Dose (MTD) (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.